December 31, 2011
Breast Implant Scare Leads To Call for Registry
Recent concerns over substandard breast implants manufactured by a now-defunct French firm have led to renewed calls for the formation of a registry that would keep track of patients who had received implants, various media outlets reported Friday.
Earlier this month, it was revealed that as many as 300,000 women worldwide had received Poly Implant Prothese (PIP) implants manufactured with cheaper, industrial grade silicone instead of the medical-grade materials typically used.
The incident has led advocates to renew calls for government health officials to create a database that would make it easier to track trends involving ruptures, infections, or other complication as they arise, Anna Yukhananov of Reuters reported on Friday.
"To this day, none exists for the world's largest healthcare market, which often serves as a global model for regulatory practice. Some individual countries in Europe have made their own attempts but with only limited success, and there is no continent-wide registry," she added.
"If we had had registries, we would have known years ago if it's true that PIP implants break sooner," Diana Zuckerman, president of the U.S. National Research Center for Women & Families, said, according to the Xinhua news agency. "We would have known if Mentor ones break sooner or later than Allergan's [two of the largest American breast implant manufacturers]."
According to Yukhananov, safety issues related to silicone implants, which had been banned by the FDA in 1992 due to health issues but permitted to return to the market five years ago, are tracked solely by "company-funded efforts" in the U.S.
In fact, the approval given to both Allergan and Mentor was conditional, requiring each company to follow 40,000 women who received the implant over the course of a decade.
"In August, Allergan said it had only collected two-year data for 60 percent of participants, while Mentor only had three-year data for 21 percent," Yukhananov said. "Consumer and patient groups have criticized the two companies for failing to meet the goals. They have asked the FDA to revoke Mentor's marketing approval and to force Allergan to conduct further studies."
"In addressing low response rates, representatives of both companies said the studies may have tried to keep track of too many patients and included overly cumbersome requirements, such as filling out a 27-page questionnaire each year," she added. Allergan had offered small cash rewards to patients to participate in the study, while both implant manufacturers gave incentives to doctors.
Both companies have expressed their support for a federal registry, Reuters said. However, companies, doctors and regulators are at odds over who wound fund such a registry, whether or not participation will be mandatory, and how the information will remain private and confidential.
"They have fiddled around with this issue (of registries) for over 20 years, and nothing has been done," Sybil Niden Goldrich, a consumer advocate and a patient who had breast implants rupture back in the late 1980s, told Yukhananov. "We still don't have an accurate rupture rate on these products."
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